510(k) Report

FDA applicant

Texas Medical Products, Inc.

Mchenry, IL30 decisions1980–19892 recalls

FDA records 30 decisions for Texas Medical Products, Inc. (Mchenry, IL) from 1980 to 1989: 30 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTL (Adaptor, Stopcock, Manifold, Fitting…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Texas Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Texas Medical Products, Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Texas Medical Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Texas Medical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass8decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass5decisions
  • KRIAccessory Equipment, Cardiopulmonary Bypass3decisions
  • DWSInstruments, Surgical, Cardiovascular1decision
  • KRJFilter, Prebypass, Cardiopulmonary Bypass1decision
  • JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass1decision

Also: DXC (1), FNY (1), DTS (1), DTR (1), DTZ (1), FXX (1).

What has FDA decided for it lately?

  • K893417Surgifresh Sub-Micron Mask NO. 901008-000Texas Medical Products, Inc. · 1989
  • K870932Surgifresh Surgical Smoke RemovalTexas Medical Products, Inc. · 1987
  • K851575DR. Bruno Lnage Mini PhotometerTexas Medical Products, Inc. · 1985
  • K830634Cardiotomy FilterTexas Medical Products, Inc. · 1983
  • K813587Disposable Thoracic CatheterTexas Medical Products, Inc. · 1982
  • K810515Disposable 2-Stage CannulaTexas Medical Products, Inc. · 1981
  • K810532Disposable StopcockTexas Medical Products, Inc. · 1981
  • K810395Pre-Bypass FilterTexas Medical Products, Inc. · 1981

All 30 as Texas Medical Products, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K801404Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR…Sep 18, 2014Class II
  • K801393Pediatric Air Aspirator Needle manufactured by Novosci Corp., The Woodlands, TXNov 24, 2003